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600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL Suspension Under Fasting Conditions

NCT00840099 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-08-20

Study results available
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Summary

The objective of this study is to assess the bioequivalence between Amoxicillin and Clavulanate Potassium for Oral Suspension, 600/42.9 mg/5 mL and Augmentin ES-600™ for Oral Suspension, 600/42.9 mg/5 mL in healthy, male and female subjects, under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

600 mg Amoxicillin/42.9 mg Clavulanate Postassium /5 mL

1 x 600 mg/42.9 mg/5 mL, single-dose fed

DRUG

Augmentin ES-600™ 600 mg/42.9 mg/5 mL Suspension

1 x 600 mg/42.9 mg/5 mL, single-dose fed

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Principal Investigators

  • Xueyu (Eric) Chen, M.D., Ph. D. · Pharma Medica Research, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2002-08-31
Completion
2002-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00840099 on ClinicalTrials.gov